Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Cleaning of Alu-Alu Packing Machine, which is commonly used in the pharmaceutical industry for packaging tablets or capsules in aluminum-aluminum blister packs.

1. Objective

To provide a standardized procedure for cleaning the Alu-Alu Packing Machine to ensure the removal of any residues, maintain the integrity of the packaging process, and prevent cross-contamination.

2. Scope

This SOP applies to the cleaning of all Alu-Alu packing machines used in the pharmaceutical industry for packing tablets, capsules, and other solid oral dosage forms.

3. Responsibility

• Machine Operator / Technician: Responsible for performing the cleaning as per this SOP.

• Production Supervisor: Ensures compliance with this SOP during the cleaning process.

• QA/QC Personnel: Verifies and approves the cleanliness of the machine after cleaning.

4. Materials and Equipment Required

• Purified Water or WFI (Water for Injection)

• Approved Cleaning Agent (detergent)

• Soft brushes / lint-free cloths

• Vacuum cleaner (optional)

• Alcohol-based disinfectant (if required)

• PPE (gloves, mask, gown, goggles)

• Cleaning Logbook

5. Procedure

5.1 Pre-Cleaning Steps

1. Power Off the Machine:

   • Turn off the machine and disconnect it from the electrical supply.

   • Display a “Under Cleaning” notice on the equipment.

2. Wear Appropriate PPE:

   • Ensure that all operators wear proper PPE (gloves, gown, mask, goggles) during cleaning.

3. Remove All Product Residues:

   • Remove any leftover blister packs, product remnants, or packaging materials from the machine.

   • Inspect the machine for any leftover tablet or capsule pieces and dispose of them properly.

4. Clear the Film Feeder Area:

   • Ensure that the aluminum film (both foil and PVC) is cleared from the film feed and packaging path.

5.2 Cleaning Procedure

1. Dry Cleaning:

   • Use a vacuum cleaner or soft brush to remove any loose powder, product, or debris from the machine parts, including the feeding area, sealing station, and conveyor.

2. Cleaning of Contact Parts (Tray, Sealing Rollers, and Blister Forming Tool):

   • Disassemble the machine according to the manufacturer’s guidelines.

   • Clean all product-contact parts (such as trays, sealing rollers, blister forming tools) with a soft cloth or brush, dampened with an approved detergent solution.

   • Focus on cleaning any product residues that might remain in the blister cavities or between the sealing rollers.

3. Cleaning the Film Feed Area:

   • Wipe down the film feeding area with a damp cloth to remove any dust or film particles.

   • Ensure that no film residue is left on any rollers or surfaces.

4. Cleaning the Machine Housing:

   • Use a soft cloth soaked in an approved cleaning solution to clean the external machine housing, control panel, and non-product contact areas.

5. Rinsing and Disinfection:

   • Use purified water or WFI to rinse the cleaned components to remove any detergent residues.

   • If required, disinfect the machine using an alcohol-based disinfectant or other approved cleaning agents.

   • Wipe any parts that came into contact with the product to ensure no chemical residues are left.

5.3 Drying and Reassembly

1. Drying the Parts:

   • Dry all cleaned components thoroughly using clean, lint-free cloths and/or compressed air.

   • Ensure that no moisture remains on any parts, particularly the sealing rollers, trays, and forming tools.

2. Reassemble the Machine:

   • After ensuring all parts are dry, reassemble the Alu-Alu packing machine as per the manufacturer’s instructions.

6. Post-Cleaning Activities

1. Label the Equipment:

   • Affix a “CLEANED” label to the machine with the date, time, and initials of the operator who performed the cleaning.

2. Document the Cleaning Activity:

   • Record the cleaning in the cleaning logbook, including time, date, cleaning agent used, and any observations encountered during cleaning.

3. Inspection and Functionality Check:

   • Perform a visual inspection to verify the cleanliness of the machine.

   • Ensure that the machine is functioning properly before it is put back into service.

7. Precautions

• Do not use harsh abrasives or cleaning agents that may damage the delicate parts of the machine, such as sealing rollers and forming tools.

• Ensure that electrical components (such as the control panel) are not exposed to water or cleaning solutions.

• Handle all machine parts with care, particularly sensitive components like trays and rollers.

• Do not skip the drying step to prevent any moisture from interfering with the packaging process.

8. References

• Alu-Alu Packing Machine Operating Manual

• GMP Guidelines

• Cleaning Validation Protocol

• Cleaning Agent Approval Documents

🎓 Discover one of the best Pharmaceutical Production courses available — click below to explore the course that’s shaping future Production skills.

https://trcjw.on-app.in/app/oc/338669/trcjw